Gait Disorder, SensorimotorNCT04062292
Gait Parameters and Balance in Patients With Obstructive Lung Diseases
An observational study of Gait Disorder, Sensorimotor, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, most of the studies examining the gait characteristics and balance separately or examining the relationship between them are on patients with COPD. No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma was found.A convincing link between gait… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorder, Sensorimotor
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2019to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The obstructive lung diseases from every subgroups: COPD, asthma and bronchiectasis patients
Who may be able to join
- Being diagnosed with obstructive lung disease,
- Have not experienced acute exacerbation or infection in the last 1 week,
- To be between 18-65 years,
- Volunteering for research,
- To be able to walk and cooperate.
Who cannot join
- Use walking aid or be chronic oxygen support
- To have orthopedic or neuromuscular comorbidities that may affect walking patterns.
- Having had lung cancer, sarcoidosis, tuberculosis disease or lung surgery.
- Inclusion Criteria for Healthy People 1.18-65 years of age, 2. Volunteer to participate in the research, 3. To be able to walk and cooperate.
- Having any cardiopulmonary disease,
- To have an advanced orthopedic disease that may affect functional capacity measurement and gait patterns.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Naciye Vardar-Yagli
Ankara, 06100
Naciye Vardar-Yagli, PhD, +903123051576 ext. 123, naciyevardar@yahoo.com
Melda Saglam, PhD
About this study
Official title: Investigation of Gait Parameters and Balance in Patients With Obstructive Lung Diseases
In the literature, most of the studies examining the gait characteristics and balance separately or examining the relationship between them are on patients with COPD.
No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma was found.A convincing link between gait disturbances and falls in COPD patients is still unknown and further research is needed. Therefore, the purpose of our study; gait parameters and balance in individuals with obstructive pulmonary disease. We will also examine the relationship between gait parameters and extrapulmonary clinical indicators of these individuals.
Read the detailed description
Patients with COPD call walking as one of the most problematic activities in daily life. Patients with COPD walk less in daily life than their healthy peers. Gait characteristics of extrapulmonary comorbidities that probably affect the musculoskeletal and cardiovascular system vary. The gait assessment gives an idea about the biomechanical factors associated with a reduction in walking distance in COPD patients. In patients with COPD, after the onset of shortness of breath or leg fatigue, a decrease in cadence during walking, shortened stride length, an increase in the time spent in the double support period, an increase in the peak ankle dorsi flexion moment is observed. During gait, there is an increase in balance disorders in the mediolateral direction. In addition, patients with COPD walk on a constant speed treadmill with more stride time and less step width variability. Studies have shown that patients with COPD have increased temporal walking characteristics, decreased step and stride length, and increased walking variability.
In the literature, most of the studies that examine gait characteristics and balance separately or examine the relationship between them are on patients with COPD. No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma has been found. A persuasive link between walking disorders and falls in COPD patients is still unknown and further research is needed. This study will contribute to clarifying the mechanisms of why the balance studied in patients with COPD is adversely affected.
- Conditions
- Gait Disorder, Sensorimotor
- Keywords
- balance, chronic obstructive diseases
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive lung diseases group | 1. Having been diagnosed with obstructive pulmonary disease, 2. No acute exacerbation or infection in the past 1 week, Being between the ages of 18 and 65, | |
| Healthy group | Age and sex matched healthy subjects without orthopedic and chronic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters
Gait parameters will be assessed with Biodex Gait Trainer (Biodex Medical Systems, Shirley, New York) for six minutes.
Measured: 01.09.2020-08.07.2021
Secondary outcomes (5)
Functional Balance and Fall Risk
Timed Up and Go Test
Measured: 01.09.2020-08.07.2021
Functional Exercise Capacity
6 minute walking test with Moxy device on M.Vastus Lateralis
Measured: 01.09.2020-08.07.2021
Respiratory Muscle Strength
Respiratory muscle strength parameters (maximal inspiratory and maximal expiratory pressure) measurement using mouth pressure device
Measured: 01.09.2020-08.07.2021
Peripheral Muscle Strength
Muscle strength of the knee extensors, hip extensors, shoulder abductors, trunk flexors and trunk extensors will be evaluated by hand dynamometer (Lafayette Manual Muscle Tester Model 01165-USA). Jamar Hand Dynamometer (USA) will measure the hand grip force
Measured: 01.09.2020-08.07.2021
Cognitive Status
Mini Mental Test
Measured: 01.09.2020-08.07.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start17 Jul 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorder, SensorimotorStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naciye Vardar-Yagli, Hacettepe University
- Investigators
- Naciye Vardar-Yagli, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062292
- Sponsor's protocol ID
- GO 19/665
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2019
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Gait Parameters and Balance in Patients With Obstructive Lung Diseases
- ClinicalTrials.gov ID
- NCT04062292
- Acronym / sponsor ID
- GO 19/665
- Conditions
- Gait Disorder, Sensorimotor
- Keywords
- balance, chronic obstructive diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the literature, most of the studies examining the gait characteristics and balance separately or examining the relationship between them are on patients with COPD.
No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma was found.A convincing link between gait disturbances and falls in COPD patients is still unknown and further research is needed. Therefore, the purpose of our study; gait parameters and balance in individuals with obstructive pulmonary disease. We will also examine the relationship between gait parameters and extrapulmonary clinical indicators of these individuals.
Detailed description
Patients with COPD call walking as one of the most problematic activities in daily life. Patients with COPD walk less in daily life than their healthy peers. Gait characteristics of extrapulmonary comorbidities that probably affect the musculoskeletal and cardiovascular system vary. The gait assessment gives an idea about the biomechanical factors associated with a reduction in walking distance in COPD patients. In patients with COPD, after the onset of shortness of breath or leg fatigue, a decrease in cadence during walking, shortened stride length, an increase in the time spent in the double support period, an increase in the peak ankle dorsi flexion moment is observed. During gait, there is an increase in balance disorders in the mediolateral direction. In addition, patients with COPD walk on a constant speed treadmill with more stride time and less step width variability. Studies have shown that patients with COPD have increased temporal walking characteristics, decreased step and stride length, and increased walking variability.
In the literature, most of the studies that examine gait characteristics and balance separately or examine the relationship between them are on patients with COPD. No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma has been found. A persuasive link between walking disorders and falls in COPD patients is still unknown and further research is needed. This study will contribute to clarifying the mechanisms of why the balance studied in patients with COPD is adversely affected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive lung diseases group | – | –1. Having been diagnosed with obstructive pulmonary disease, 2. No acute exacerbation or infection in the past 1 week, Being between the ages of 18 and 65, |
| Healthy group | – | –Age and sex matched healthy subjects without orthopedic and chronic diseases |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The obstructive lung diseases from every subgroups: COPD, asthma and bronchiectasis patients
Key inclusion criteria (5 listed)
- Being diagnosed with obstructive lung disease,
- Have not experienced acute exacerbation or infection in the last 1 week,
- To be between 18-65 years,
- Volunteering for research,
- To be able to walk and cooperate.
Key exclusion criteria (6 listed)
- Use walking aid or be chronic oxygen support
- To have orthopedic or neuromuscular comorbidities that may affect walking patterns.
- Having had lung cancer, sarcoidosis, tuberculosis disease or lung surgery.
- Inclusion Criteria for Healthy People 1.18-65 years of age, 2. Volunteer to participate in the research, 3. To be able to walk and cooperate.
- Having any cardiopulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait parameters
Time frame: 01.09.2020-08.07.2021
Gait parameters will be assessed with Biodex Gait Trainer (Biodex Medical Systems, Shirley, New York) for six minutes.
5 secondary outcomes
Functional Balance and Fall Risk
Time frame: 01.09.2020-08.07.2021
Functional Exercise Capacity
Time frame: 01.09.2020-08.07.2021
Respiratory Muscle Strength
Time frame: 01.09.2020-08.07.2021
Peripheral Muscle Strength
Time frame: 01.09.2020-08.07.2021
Cognitive Status
Time frame: 01.09.2020-08.07.2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naciye Vardar-Yagli, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Disorder, Sensorimotor, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naciye Vardar-Yagli, PhD (+903123051576 ext. 123, naciyevardar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameters (time frame: 01.09.2020-08.07.2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.